Alerte De Sécurité sur Enzygnost Syphilis, Record: 10345161559. Presentation: Content for: 192 determinations (2 x 96); Content for: 960 determinations (10 x 96). Lots: 42912; 43035; 43508; 43901.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Proudcts GmbH.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1464
  • Date
    2014-10-29
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    All wells on an affected plate have consistently shown decreased absorbance values. Since the absorbance values ​​are below the validation limit, the board may become invalid. As indicated in the package insert, the test must be repeated if Reference N is below the limit of validation. The overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as low health risk, its severity being high and its probability of occurrence extremely unlikely. #### UPDATED ON 08/21/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    The manufacturer siemens healthcare diagnostics products gmbh has detected through complaints that in rare cases an enzygnost® sifilis tablet may have low absorbance values ​​by reference n enzygnost® syphilis anti-t. pallidum. in such cases, the reference n absorbance values ​​may be near or lower than the validation limit.
  • Action
    The registration holder in Brazil advises customers to discontinue use of the product, segregate any remaining stock from the affected lot of Enzygnost Syphilis in order to return these products to Siemens and to keep the letter with the laboratory records. Letter attached.

Manufacturer